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Dental File ( Micro Shaper）
EUDAMEDClass I (EU MDR)
Ref 008 03S、17mm LModel H Shaper: 008 03,010 03,015 02,020 02,025 02,030 02,035 02,040 02. K Shaper: 008 03,010 03,015 02,020 02,025 02,030 02,035 02,040 02, 010 04,010 06,015 04. F Shaper: 015 05,020 05,025 05,030 05Ref 025 002
Identity
- Trade Name
- Dental File ( Micro Shaper） EUDAMEDMicro Shaper EUDAMED
- Device Name
- Dental File (Micro Shaper） EUDAMED
- Model / Reference
- H Shaper: 008 03,010 03,015 02,020 02,025 02,030 02,035 02,040 02. K Shaper: 008 03,010 03,015 02,020 02,025 02,030 02,035 02,040 02, 010 04,010 06,015 04. F Shaper: 015 05,020 05,025 05,030 05 EUDAMED008 03S、17mm L EUDAMED025 002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942200960521 EUDAMED06942200960644 EUDAMED
- Basic UDI-DI
- 69422009MicroShaper59 EUDAMED
- EMDN Code
- Q010507 ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France EUDAMEDGermany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Dental File ( Micro Shaper） by Shanwei Perfect Medical Instruments Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 69422009MicroShaper59 | Class I | Active |
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Manufacturer
- Manufacturer
- Shanwei Perfect Medical Instruments Co., Ltd.
- EUDAMED SRN
- CN-MF-000033003
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (3)
- EUDAMED 497b0d40-8193-48e7-8d0b-50fbd42df9a8 61 fields · synced Oct 6, 2026
- EUDAMED 150d4259-fa0a-4332-b897-539ab2c04885 61 fields · synced Jul 8, 2026
- EUDAMED bfbff377-a708-48ed-b3a9-1fb522c84e05 61 fields · synced Jul 22, 2026